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CPOG provides information to interested individuals on a number of ongoing research
protocols. There are no currently open CPOG protocols but,
there are several pharmaceutical trials and other
clinical trials offered at Penn State Hershey Medical Center.
What is a Clinical Trial/ Research Protocol?
In cancer research, a clinical trial is a study designed to answer scientific
questions. Some clinical trials test new treatments, investigate new ways of preventing
cancer and monitor the quality of life and/or psychological impact of cancer while others
detect cancer in its earliest stages.
Clinical research is the bridge between basic laboratory research and what is made
available to the patient. Once drug development has been completed from initial laboratory
studies, clinical trials progress through phases of testing. The trials are identified as
Phase I, Phase II, Phase III.. Each phase of a clinical trial protocol attempts to answer
questions that will enhance and improve cancer treatment and therapies.
Phase I
Phase I studies test a particular treatment in humans after it has been studies in the
laboratory. The purpose of Phase I studies is to determine the maximum tolerated dose or
amount of the treatment and answer questions about the best way to give the new treatment.
Phase I studies are carefully controlled by the NCI’s Regulatory Affairs Branch with
the Cancer Therapy Evaluation Program (CTEP). Phase I studies are carried out by
knowledgeable investigators who meet certain criteria set by CTEP.
Phase II
Once Phase I studies have been completed and a dosage level is known, Phase II studies
can start. Phase II studies test the treatment in humans in various types of cancer to
determine the effectiveness of the agent against a given tumor type. Additional
information on side effects may also be gained.
Phase III
If treatment is found to be effective, Phase III studies compare it to the standard
treatment. This is done by having two or more "arms" of treatment in which
patients are randomly selected to participate. The arm in which the patient participates
is decided by chance (by computer) not choice. This randomization assists in making the
groups as equal as possible so that sound conclusions can be drawn from study results.
Patients are randomized by a number of factors that may affect the outcome of the study
(age, performance status, tumor grade, stage of disease, etc…). In all treatment
arms, patients receive the best care available.
Informed Consent
Every patient participating in a medical research study, by law in the United States,
must sign an informed patient consent form that explains the research study, the
foreseeable risks, benefits other appropriate treatments, and where to find further
information. It also explains a patient’s rights as a participant in the trial. If at
anytime a participant is not comfortable with the trial, they have the right to withdraw.
Also confidentiality of patient’s records is assured.
CPOG Protocol # 92-05
Title: High Dose Chemotherapy of Small Cell Lung Cancer - to determine 1) safety of
high dose CTX therapy + G-CSF following induction with VP16/Cisplatinum in Oat Cell Lung
Cancer, 2) the level of dose intensity that can be achieved with the support of G-CSF, and
3) the response rate and survival of patients treated with the treatment.
This trial is now CLOSED.
Newly opened investigator initiated trial using
sunitinib for patients with malignant ascites. This trial is
based on an our observation that one of our patients with
malignant ascites had resolution of his ascites while on
sunitinb despite overall disease progression. Patients can have
any solid tumor diagnosis but can not concurrently be receiving
other treatments. Sutent will be provided free of charge for as
long as the patient is responding. Patients with brain metastases
are excluded. Please contact Leah Cream, MD
717-531-7309 for more information or to refer a patient.
For more information
about any treatment protocols, please contact Cynthia Campbell-Baird at ccampbell@psu.edu
The Oncology clinical trials office can be contacted at (717)
531-5777.
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